510(k) · Cleared

Cleared

Manual Wheelchair, Model A011

K201461510(k) TraditionalCleared May 21, 2021353-day reviewClass I21 CFR 890.3850

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ningbo Shenyu Medical Equipment Co.,Ltd · IOR Wheelchair, Mechanical

Cleared on May 21, 2021 as substantially equivalent to K181795 (Sichuan Ast Medical Equipment Co., Ltd., 2018) after a 353-day review. Its family tree reaches back 3 generations to 1994. 12 later devices descend from it.

Decided: May 21, 2021
Review: 353 days
Class: Class I
Product code: IOR
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K935398 (1994). 12 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 3 generations backK935398 Tracer Series Manual WheelchairsInvacare Corp. · 1994
2 generations backK162621 Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy…Invacare Corporation · 2017
1 generation backK181795 AST Model MA012 and MS019 Rehab WheelchairSichuan Ast Medical Equipment Co., Ltd. · 2018
This deviceK201461 Manual Wheelchair, Model A011Ningbo Shenyu Medical Equipment Co.,Ltd · 2021
Descendant · cites it directly · 3 of its ownK232198 Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D…Zhenjiang Assure Medical Equipment Co., Ltd. · 2023
Descendant · cites it directly · 2 of its ownK232230 YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE…Zhenjiang Assure Medical Equipment Co., Ltd. · 2023
Descendant · cites it directly · 1 of its ownK232199 Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE…Zhenjiang Assure Medical Equipment Co., Ltd. · 2023
Descendant · cites it directly · 0 of its ownK261919 Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd. · 2026
Descendant · 2 generations on · 0 of its ownK260144 Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd. · 2026

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2023high 6 (2026) · low 1 (2024)2026

Most influential descendants

Showing 5 of 12 · See all

K232198Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S…Zhenjiang Assure Medical Equipment Co., Ltd. · 2023 · cites it directly3descendants
K232230YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F…Zhenjiang Assure Medical Equipment Co., Ltd. · 2023 · cites it directly2descendants
K232199Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS…Zhenjiang Assure Medical Equipment Co., Ltd. · 2023 · cites it directly1descendant
K261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd. · 2026 · cites it directly0descendants
K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd. · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K935398	Tracer Series Manual Wheelchairs	Invacare Corp.	1994	—
−2	K162621	Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra…	Invacare Corporation	2017	—
−1	K181795	AST Model MA012 and MS019 Rehab Wheelchair	Sichuan Ast Medical Equipment Co., Ltd.	2018	—
0 (this device)	K201461	Manual Wheelchair, Model A011	Ningbo Shenyu Medical Equipment Co.,Ltd	2021	—
+1	K232198	Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S…	Zhenjiang Assure Medical Equipment Co., Ltd.	2023	—
+1	K232230	YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18…	Zhenjiang Assure Medical Equipment Co., Ltd.	2023	—
+1	K232199	Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B…	Zhenjiang Assure Medical Equipment Co., Ltd.	2023	—
+1	K261919	Multifunctional wheelchair (YJ-059)	Zhenjiang Assure Medical Equipment Co., Ltd.	2026	—
+2	K260144	Reclining wheelchair (YJ-013L)	Zhenjiang Assure Medical Equipment Co., Ltd.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	4	0
2024	1	0
2025	1	0
2026	6	0

FIG. 1 — Lineage of K201461, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IOR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IOR device

#1 K232198 Reclining wheelchair (YJ-011S 16”D, YJ-011S…score 15.9 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K181795	AST Model MA012 and MS019 Rehab Wheelchair Summary page 4 …mber: 890.3850 Review Panel: Physical Medicine III. Predicate device: Sichuan AST Medical Equipment Co., Ltd. AST Model MA012 and MS019 Rehab Wheelchair 510Knumber: K181795 This predicate has not been subject to a design-related recall. IV. Device Description A mechanical wheelchair is a chair…	Sichuan Ast Medical Equipment Co., Ltd.	2018	—

Also cleared against K181795: 5 other devices →

What descends from it? (12)

See all 12

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K232198	Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S…	Zhenjiang Assure Medical Equipment Co., Ltd.	2023	3
K232230	YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F…	Zhenjiang Assure Medical Equipment Co., Ltd.	2023	2
K232199	Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS…	Zhenjiang Assure Medical Equipment Co., Ltd.	2023	1
K261919	Multifunctional wheelchair (YJ-059)	Zhenjiang Assure Medical Equipment Co., Ltd.	2026	0
K241460	Manual Wheelchair	Lichtmega Technology Co., Ltd.	2024	0
K231110	Manual Wheelchair (A006)	Ningbo Shenyu Medical Equipment Co.,Ltd	2023	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K232198 (Zhenjiang Assure Medical Equipment Co., Ltd., 2023) has gone furthest, with 3 descendants of its own.
5 other devices also cite its predicate K181795.

How does its category compare?

All IOR devices

IOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · IOR

17so far in 2026, the most since 2007

2007high 17 (2026) · low 2 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IOR

91in 2025

2007high 233 (2013) · low 32 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IOR

1in 2021

2007high 6 (2011) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IOR

135in 2025

2007high 5,082 (2014) · low 36 (2007)2025

MAUDE reports naming product code IOR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	5	38	1	36
2008	13	32	3	62
2009	4	43	2	54
2010	12	81	0	69
2011	6	58	6	232
2012	11	176	3	1,238
2013	7	233	3	4,674
2014	7	211	3	5,082
2015	3	104	0	4,472
2016	10	135	1	1,860
2017	7	209	0	49
2018	3	203	0	58
2019	6	160	0	53
2020	2	—	0	43
2021	2	—	1	59
2022	4	150	0	37
2023	9	61	0	165
2024	4	65	0	138
2025	7	91	0	135
2026	17	103	0	—

What is it indicated for?

The A011 Manual Wheelchair is to provide mobility to persons limited to a sitting position.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K201461 · printed Nov 3, 2026

Cite this page

510(k) Report. “K201461: Manual Wheelchair, Model A011.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201461

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026